EP4051246A1 - Zweischichtige brausetablettenformulierungen mit dapagliflozin und metformin - Google Patents

Zweischichtige brausetablettenformulierungen mit dapagliflozin und metformin

Info

Publication number: EP4051246A1
Authority: EP; European Patent Office
Prior art keywords: weight; release layer; bilayer tablet; immediate release; extended release
Prior art date: 2019-10-31
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.): Granted

Application number

EP20881133.1A

Other languages

English (en)

French (fr)

Other versions

EP4051246A4 (de

EP4051246B1 (de

Inventor

Abdullah TASKIN

Yavuz Dedeoglu

Muge ULUSOY BOZYEL

Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)

Sanovel Ilac Sanayi ve Ticaret AS

Original Assignee

Sanovel Ilac Sanayi ve Ticaret AS

Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)

2019-10-31

Filing date

2020-10-27

Publication date

2022-09-07

2020-10-27 Application filed by Sanovel Ilac Sanayi ve Ticaret AS filed Critical Sanovel Ilac Sanayi ve Ticaret AS

2022-09-07 Publication of EP4051246A1 publication Critical patent/EP4051246A1/de

2023-11-15 Publication of EP4051246A4 publication Critical patent/EP4051246A4/de

2026-03-18 Application granted granted Critical

2026-03-18 Publication of EP4051246B1 publication Critical patent/EP4051246B1/de

Status Active legal-status Critical Current

2040-10-27 Anticipated expiration legal-status Critical

Links

Classifications

- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Definitions

said binders comprise at least one of polyvinylpyrrolidone (povidone), hydroxypropylmethylcellulose, hydroxypropylcellulose, carboxymethylcellulose, methyl cellulose, ethyl cellulose, poliox, xantum gum and gelatin, or mixtures thereof.
polyvinylprolidone is used in the first layer, hydroxypropylmethylcellulose or carboxymethylcellulose or polyox or xanthan gum in the second layer.
the amount of disintegrant in the first layer is 0,1 to 10% by weight, preferably 1 to 7%, more preferably 3 to 5% by weight in the total composition in the first layer.
the amount of glidant in the second layer is 0,01 to 5% by weight, preferably 0,05 to 3%, more preferably 0,1 to 2% by weight in the total composition in the second layer.
An embodiment of the present invention is a method for preparing a bilayer tablet formulation, wherein
the immediate release layer Polyvinylprolidone is dissolved in alcohol, then iron oxide is added and mixed. Dapagliflozin, metformin, microcrystalline cellulose mixture is granulated with this solution, dried and sieved. A homogeneous powder mixture is obtained by adding the remaining excipients.

Landscapes

Health & Medical Sciences (AREA)
Chemical & Material Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Public Health (AREA)
Medicinal Chemistry (AREA)
Pharmacology & Pharmacy (AREA)
Animal Behavior & Ethology (AREA)
General Health & Medical Sciences (AREA)
Veterinary Medicine (AREA)
Epidemiology (AREA)
Engineering & Computer Science (AREA)
Diabetes (AREA)
Bioinformatics & Cheminformatics (AREA)
Emergency Medicine (AREA)
Endocrinology (AREA)
Molecular Biology (AREA)
Hematology (AREA)
Obesity (AREA)
Chemical Kinetics & Catalysis (AREA)
General Chemical & Material Sciences (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Organic Chemistry (AREA)
Inorganic Chemistry (AREA)
Medicinal Preparation (AREA)
Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

EP20881133.1A 2019-10-31 2020-10-27 Zweischichtige brausetablettenformulierungen mit dapagliflozin und metformin Active EP4051246B1 (de)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
TR2019/16829A TR201916829A2 (tr)	2019-10-31	2019-10-31	Dapagli̇flozi̇n ve metformi̇n i̇çeren çi̇ft katmanli tablet formülasyonlari
PCT/TR2020/050996 WO2021086292A1 (en)	2019-10-31	2020-10-27	Bilayer tablet formulations comprising dapagliflozin and metformin

Publications (3)

Publication Number	Publication Date
EP4051246A1 true EP4051246A1 (de)	2022-09-07
EP4051246A4 EP4051246A4 (de)	2023-11-15
EP4051246B1 EP4051246B1 (de)	2026-03-18

Family

ID=75716198

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
EP20881133.1A Active EP4051246B1 (de)	2019-10-31	2020-10-27	Zweischichtige brausetablettenformulierungen mit dapagliflozin und metformin

Country Status (3)

Country	Link
EP (1)	EP4051246B1 (de)
TR (1)	TR201916829A2 (de)
WO (1)	WO2021086292A1 (de)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
TR202019590A2 (tr) *	2020-12-03	2022-06-21	Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi	Dapagli̇flozi̇n ve metformi̇n hi̇droklorür formülasyonlarina yöneli̇k bi̇r proses
WO2022119543A1 (en) *	2020-12-03	2022-06-09	Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi	A process for tablet formulations comprising amorphous dapagliflozin and metformin hydrochloride
TR202019592A2 (tr) *	2020-12-03	2022-06-21	Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi	Amorf dapagliflozinin katı farmasötik formülasyonları
EP4212150A1 (de) *	2022-01-13	2023-07-19	Sanovel Ilac Sanayi Ve Ticaret A.S.	Zweischichtige tablettenzusammensetzung mit amorphem dapagliflozin und metformin
WO2026003869A1 (en) *	2024-06-26	2026-01-02	Manish Goswami	Modified release oral tablets for management of diabetes and preparation method thereof

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
WO2010045656A2 (en)	2008-10-17	2010-04-22	Nectid, Inc.	Novel sglt2 inhibitor dosage forms
CN102711739B (zh)	2009-11-13	2015-12-16	阿斯利康(瑞典)有限公司	双层片剂
CN103037849A (zh) *	2010-06-22	2013-04-10	安成国际药业股份有限公司	具有减少的食物效应的控释组合物

2019
- 2019-10-31 TR TR2019/16829A patent/TR201916829A2/tr unknown
2020
- 2020-10-27 WO PCT/TR2020/050996 patent/WO2021086292A1/en not_active Ceased
- 2020-10-27 EP EP20881133.1A patent/EP4051246B1/de active Active

Also Published As

Publication number	Publication date
EP4051246A4 (de)	2023-11-15
TR201916829A2 (tr)	2021-05-21
WO2021086292A1 (en)	2021-05-06
EP4051246B1 (de)	2026-03-18

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2023-11-15	RIC1	Information provided on ipc code assigned before grant	Ipc: A61P 3/10 20060101ALI20231011BHEP Ipc: A61K 31/351 20060101ALI20231011BHEP Ipc: A61K 31/155 20060101ALI20231011BHEP Ipc: A61K 9/20 20060101AFI20231011BHEP
2025-01-01	RAP3	Party data changed (applicant data changed or rights of an application transferred)	Owner name: SANOVEL ILAC SANAYI VE TICARET ANONIM SIRKETI
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